title: Comparable safety and antiemetic efficacy of a brief (30-second bolus) intravenous granisetron infusion and a standard (15-minute) intravenous ondansetron infusion in breast cancer patients receiving moderately emetogenic chemotherapy.
abstract: OBJECTIVE
  For patients receiving chemotherapy, optimization of antiemetic therapy in terms of safety of administration, efficacy, cost, and convenience remains a subject of intense clinical research. In this study, we evaluated and compared the safety and antiemetic efficacy of a single 30-second intravenous bolus infusion of granisetron which those of a standard 15-minute intravenous infusion of ondansetron in chemotherapy-naive breast cancer patients receiving moderately emetogenic chemotherapy.
  
  
  METHODS
  This was a randomized, double-blind, double-dummy, multicenter crossover study of 623 chemotherapy-naive patients (two male, 621 female) receiving moderately emetogenic chemotherapy (cyclophosphamide plus doxorubicin, with or without 5-fluorouracil) for breast cancer. Patients were assigned randomly to receive either granisetron or ondansetron in cycle 1 and the other agent in cycle 2. Granisetron (10 micrograms/kg) was administered as a 30-second intravenous bolus infusion within 5 minutes before the start of chemotherapy, and ondansetron (32 mg) was administered as a 15-minute intravenous infusion beginning 30 minutes before the start of chemotherapy. A total of 573 patients received the two planned chemotherapy cycles. Safety assessment was based on the type and frequency of adverse experiences reported by the patient at 24 and 48 hours after chemotherapy began. Efficacy assessments included the occurrence of nausea or emesis and the proportion of patients who achieved total emetic control at 24 and 48 hours after chemotherapy.
  
  
  RESULTS
  Similar proportions of patients in both treatment groups remained free of emesis at the 24-hour assessment period (58.6% and 62.7% of granisetron- and ondansetron-treated patients, respectively) and at 48 hours (42.2% and 45.0% for granisetron vs ondansetron) in both cycles. The proportions of granisetron- and ondansetron-treated patients who remained nausea-free for the first 24 hours after treatment in both cycles were 44.0% and 48.5%, respectively, and at 48 hours were 26.7% and 31.0%, respectively. Statistical analysis demonstrated no significant treatment-by-cycle interaction. The 30-second granisetron infusion and the 15-minute ondansetron infusion were well tolerated. However, administration of ondansetron as a 15-minute intravenous infusion produced abnormal vision (6.28%) in significantly more patients than granisetron (0.35%).
  
  
  CONCLUSIONS
  These two intravenous 5-hydroxytryptamine3-receptor antagonist antiemetics were similarly effective in controlling acute nausea and emesis during two cycles of moderately emetogenic chemotherapy. Granisetron (30 seconds) and the longer infusion of ondansetron (15 minutes) were well tolerated; however, ondansetron was associated with a greater proportion of patients reporting abnormal vision. Granisetron administered as a 30-second bolus infusion allows a considerably shorter waiting time between the end of the antiemetic infusion and the initiation of chemotherapy. This shorter administration time may enhance patient convenience and provider efficiency.
authors.affiliation: Division of Hematology/Oncology, Mayo Clinic, Jacksonville, FL 32224, USA.
authors.forename: E A
authors.initials: EA
authors.lastname: Perez
authors.forename: B
authors.initials: B
authors.lastname: Lembersky
authors.forename: P
authors.initials: P
authors.lastname: Kaywin
authors.forename: L
authors.initials: L
authors.lastname: Kalman
authors.forename: K
authors.initials: K
authors.lastname: Yocom
authors.forename: C
authors.initials: C
authors.lastname: Friedman
mesh_terms: D000328:Adult; D000932:Antiemetics / Q000009:adverse effects / Q000627:therapeutic use*; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000009:adverse effects* / Q000627:therapeutic use*; D001943:Breast Neoplasms / Q000188:drug therapy*; D018567:Breast Neoplasms, Male / Q000188:drug therapy*; D018592:Cross-Over Studies; D003520:Cyclophosphamide / Q000008:administration & dosage; D004311:Double-Blind Method; D004317:Doxorubicin / Q000008:administration & dosage; D004334:Drug Administration Schedule; D005260:Female; D005472:Fluorouracil / Q000008:administration & dosage; D017829:Granisetron / Q000009:adverse effects / Q000627:therapeutic use*; D006801:Humans; D007262:Infusions, Intravenous; D008297:Male; D008875:Middle Aged; D009325:Nausea / Q000139:chemically induced / Q000517:prevention & control*; D017294:Ondansetron / Q000009:adverse effects / Q000627:therapeutic use*; D014839:Vomiting / Q000139:chemically induced / Q000517:prevention & control*
chemical_list: D000932:Antiemetics; D003520:Cyclophosphamide; D004317:Doxorubicin; D005472:Fluorouracil; D017829:Granisetron; D017294:Ondansetron